[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640415":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm",null,"Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).",[13],"Diagnostic Test: PET-MRI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","PET-MRI","1. The study participants will receive pre-treatment whole body PET\u002FMR and breast PET\u002FMR examinations.\n2. The whole body PET\u002FMR\n3. PET\u002FMR of the breast\n4. The whole body FDG PET\u002FMR, and the breast FCH PET\u002FMR will be performed on different days (interval \\>= 2 days).\n5. The study results will be interpreted by board certified diagnostic radiologists and nuclear medicine physicians, and relayed to the patient's physicians for reference of clinical management.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Jane Wang, M.D.","CONTACT","+886938591583","jwang2@vghtpe.gov.tw",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":31,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Taipei Veterans General Hospital","RECRUITING","Taipei","Taiwan","11217","TW",{"type":35,"coordinates":36},"Point",[37,38],121.52639,25.05306,{"lat":38,"lon":37},[41,42,44,47,49],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":22,"role":43,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":45,"role":46,"phone":10,"phoneExt":10,"email":10},"Ling-Ming Tseng, M.D","SUB_INVESTIGATOR",{"name":48,"role":46,"phone":10,"phoneExt":10,"email":10},"Ko-Han Lin, M.D.",{"name":50,"role":46,"phone":10,"phoneExt":10,"email":10},"Yi-Fang Tsai, M.D.",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100640415","fluorocholine-petmr-in-breast-cancer-100640415",false,"NCT07587086","Fluorocholine PET\u002FMR in Breast Cancer","Use of Imaging Markers by Fluorocholine PET\u002FMR to Predict Molecular Subtypes and Clinical Outcomes of Breast Cancer: a Pilot Study","Inclusion Criteria:\n\n* Women aged 25-75 years old.\n* Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).\n* Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.\n\nExclusion Criteria:\n\n* Women who are unable to cooperate with the examinations\n* Women who are pregnant, lactating or are planning to be pregnant\n* Women with estimated GFR (eGFR) \\\u003C 60 ml\u002Fmin\u002F1.73m2 or acute renal failure within 3 months, past history of renal dialysis.\n* Past history of claustrophobia\n* Past history of anaphylactoid reactions to MRI contrast agents or PET tracer agents.\n* Women with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (\\\u003C3 months).\n* Past history of breast cancer or other malignancy within 5 years.\n* Women who underwent chemotherapy within a year.\n* Women who are not suitable to join the study according to the assessment by investigators.","FEMALE","25 Years","75 Years",{"count":64,"type":65},195,"ESTIMATED","40 Weeks","OBSERVATIONAL","Objectives:\n\nOur study is conducted to use the pre-treatment FCH PET\u002FMR in breast cancer patients, to investigate whether the conventional PET\u002FMR imaging markers (SUVmax, MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, ADC analysis), and FCH\u002FMR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for prediction purposes.\n\nPrimary study purposes:\n\n-To investigate whether the pre-treatment FCH PET\u002FMR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for prediction purpose.\n\nSecondary study purposes:\n\n\\- To investigate whether the pre-treatment FCH PET\u002FMR imaging parameters are associated with the factors related to clinical outcomes (histologic grade, prognosis) and to analyze which parameters are more accurate for prediction purposes.\n\nTest drug:\n\nName: 18F- Fluorocholine (18F-FCH) Dosage form: N-(\\[18F\\]fluoromethyl)-2-hydroxy-N,N-dimethylethan-1-aminium Strength: 3-5 MBq\u002Fkg per patient (5-6 mCi\u002FmL at time of injection (TOI)) Dosage and administration: Intravenous injection.\n\nSelection criteria:\n\n1. Women aged 25-75 years old.\n2. Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).\n3. Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.",[70,71],"Breast Neoplasms","Female",[73,74,75,76],"Breast Cancer","FCH(18F- Fluorocholine)","Radiomics","PET\u002FMRI","2026-05-08",{"date":79,"type":80},"2026-05-14","ACTUAL",{"date":82,"type":80},"2022-06-14",{"date":84,"type":65},"2028-07-31",{"name":5,"class":6},1]